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New treatment option for Myocarditis Acute
Official title Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis
ClinicalTrials.gov ID: NCT06686862
What this study is testing
What is ibuprofen?
ibuprofen is an investigational medicine, being studied as a potential treatment for myocarditis acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Prospective, randomized, multicenter, open-label clinical trial to evaluate the safety and efficacy of a 3-week ibuprofen tapering regimen compared to conventional analgesic treatment (acetaminophen) in patients with acute myocarditis and left ventricular ejection fraction ≥50%. The objective is to assess the reduction in late gadolinium enhancement on cardiac magnetic resonance imaging at 6-month follow-up.
- Phase 3: a large, late-stage study
- Time commitment: about 3 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged 18 years or older.
- Patients hospitalized for confirmed acute myocarditis and left ventricular ejection fraction ventricular \>50%.
- Elevated troponin I/T (3 times above the upper limit of normal).
- Absence of acute heart failure.
- Absence of ischemic heart disease (ruled out by coronary angiography or coronary CT in individuals over 40 years).
You likely can't join if
- Kidney disease stage 3b, 4 and 5 (creatinine clearance by CKD-EPI \<45 ml/min/1.73 m2).
- Severe liver failure (Child-Pugh class C).
- Poorly controlled pharmacological hypertension (repeatedly systolic arterial pressure \>140 mmHg).
- Diagnosis criteria for acute pericarditis.
- Moderate or severe pericardial effusion (\>10 mm in total).
- Hypersensitivity to NSAIDs or previous use in the last 7 days.
See the full eligibility criteria
- Aged 18 years or older.
- Patients hospitalized for confirmed acute myocarditis and left ventricular ejection fraction ventricular \>50%.
- Elevated troponin I/T (3 times above the upper limit of normal).
- Absence of acute heart failure.
- Absence of ischemic heart disease (ruled out by coronary angiography or coronary CT in individuals over 40 years).
- Diagnostic criteria for myocarditis (Lake Louise, 2018 update) by cardiac magnetic resonance imaging.
- Kidney disease stage 3b, 4 and 5 (creatinine clearance by CKD-EPI \<45 ml/min/1.73 m2).
- Severe liver failure (Child-Pugh class C).
- Poorly controlled pharmacological hypertension (repeatedly systolic arterial pressure \>140 mmHg).
- Diagnosis criteria for acute pericarditis.
- Moderate or severe pericardial effusion (\>10 mm in total).
- Hypersensitivity to NSAIDs or previous use in the last 7 days.
- Contraindication for MRI.
- Participation in another clinical trial.
- Pregnancy, breastfeeding, or women of childbearing age unwilling to use appropriate contraception throughout the study.
- Any circumstance that, in the investigator's opinion, compromises participation in the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Majadahonda, Madrid, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Majadahonda, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.